Vol.56 No.S-1 April 2008
Oral tissue distribution, efficacy, and safety of sitafloxacin in patients with dentistry and oral surgery infection
1)Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, Japan
2)Department of Pharmacology, Jikei University School of Medicine
Abstract
To assess the fluoroquinolone antibacterial agent sitafloxacin(STFX) for transferability to oral tissue, efficacy, and safety in patients with dentistry and oral surgery infection, we conducted a clinical pharmacology study using STFX at 50 mg per single dose and a phase III clinical study using STFX at 50 mg or 100 mg b.i.d. for 3 to 7 days.
1. Oral tissue concentration 2.7 to 3.7 hours after a single treatment of STFX at 50 mg in 10 cases for data analysis was 0.57±0.17 μg/g in gingiva and 0.32±0.17 μg/g in extraction wound fluid, making the transfer rate 1.3±0.4 in gingiva and 0.8±0.5 in extraction wound fluid.
2. Clinical efficacy was 97.6% (41/42) rated by doctors in charge, and 85.0% (34/40) by rating ratio based on the Japanese Society of Oral Therapeutics and Pharmacology on day 3 of treatment.
3. Bacteriological elimination was 100% (37/37) at the end of treatment and 94.3% (33/35) on day 3 of treatment.
4. No adverse reactions were seen in the clinical pharmacology study, but occurred in 22 (44.9%, 33 events) of 49 cases for data analysis in the clinical study; none were severe.
These results suggest that STFX is well transferred to oral tissues and useful in the treatment of odontogenic infections at a dose of 50 mg b.i.d.
Key word
sitafloxacin, fluoroquinolone, odontogenic infection, clinical trial, tissue penetration
Received
October 5, 2007
Accepted
December 18, 2007
Jpn. J. Chemother. 56 (S-1): 121-129, 2008
